Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | April 2008 |
| End Date: | March 4, 2016 |
"A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"
Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed
by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast
cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved
area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by
interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation
therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both
the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable
to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT
when compared to radiation alone. However there is little data on how sequencing or timing of
these therapies with respect to one another affect outcome. As a result there is no consensus
about the optimal combination. There are real and potential benefits to concurrent
chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to
surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall
treatment program; and 3) may also improve local control via chemo-sensitization of residual
cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive
skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer
be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a
follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with
PBI delivered concurrently with various chemotherapy regimens.
by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast
cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved
area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by
interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation
therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both
the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable
to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT
when compared to radiation alone. However there is little data on how sequencing or timing of
these therapies with respect to one another affect outcome. As a result there is no consensus
about the optimal combination. There are real and potential benefits to concurrent
chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to
surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall
treatment program; and 3) may also improve local control via chemo-sensitization of residual
cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive
skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer
be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a
follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with
PBI delivered concurrently with various chemotherapy regimens.
1. Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects will
receive Segmental Mastectomy (Lumpectomy)
2. Medical Oncology Evaluation
3. Consent/Registration Pre-RT evaluation
4. Simulation/Treatment Planning
5. Chemo-Radiation Therapy:
ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15
fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1
(+/- 7 days of C1D1 radiation may start)
6. Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's
discretion
7. F/U Schedule
receive Segmental Mastectomy (Lumpectomy)
2. Medical Oncology Evaluation
3. Consent/Registration Pre-RT evaluation
4. Simulation/Treatment Planning
5. Chemo-Radiation Therapy:
ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15
fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1
(+/- 7 days of C1D1 radiation may start)
6. Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's
discretion
7. F/U Schedule
Eligibility Criteria:
Each of the criteria in the following section must be met in order for a patient to be
considered eligible for registration.
- Patient must be older than 18 years of age
- Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma
of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes
(pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or
sarcomas of the breast cancer are NOT eligible.
- Patient must have a history and physical within six weeks prior to the start of any
protocol therapy.
- Patient must have had a bilateral mammogram prior to surgery.
- Patients must have undergone a segmental mastectomy (SM) with a level I and ll
axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must
be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal
carcinoma. Patients who have post-operative margins which are negative but less than
2mm will be considered eligible if the surgeon states that the margin in question
could not be improved.
- Patient must have a Medical Oncology consult and be recommended to receive one of the
following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and
Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin
and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy,
hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the
medical oncologist.
- Patients must be registered such that radiation therapy begins no sooner than 7 days
prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start
chemotherapy and radiation less than 14 weeks from the last breast surgical procedure.
- Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the
current cancer.
- Patients must have a performance status 0 or 1 by ECOG criteria
- Patients must not have received prior radiation therapy to the involved breast at any
time for any reason.
- Any patient with active local-regional disease prior to registration is not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the
patient has been disease-free for 5 years.
- Patients must not be pregnant due to the potential for fetal harm as a result of this
treatment regimen. Women of child-bearing potential must use effective non hormonal
contraception while undergoing radiation therapy. Women of child-bearing potential
must also have a negative pregnancy test within six weeks prior to start of protocol
therapy.
- Patients must not have a serious medical or psychiatric illness which prevents
informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and given
written informed consent in accordance with institutional and federal guidelines.
We found this trial at
1
site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
Click here to add this to my saved trials
