CTRI/2018/12/016816
Recruiting
Phase 3
HYPOfractionated Radiation Therapy comparing a standard radiotherapy schedule (over three weeks) with a novel one week schedule in Adjuvant breast cancer: An open label randomised controlled study - HYPORT Adjuvant
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tata Medical Center
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histologically or cytologically confirmed invasive breast cancers
- •2\. ECOG performance status : 0 \- 3
- •3\. Underwent curative intent surgery for the breast cancer with complete microscopic resection either in the form of a mastectomy or breast conservation surgery
- •4\. Adequate axillary clearance or a validated sentinel node biopsy procedure. For the purpose of this study, adequacy of the axillary clearance will be determined by a multidisciplinary tumor board and rationale for the decision documented in the case records. As a general guideline, at least 10 axillary lymph nodes need to be sampled for an axillary nodal dissection to be considered as adequate.
- •5\. Absence of distant metastases. Patients who have high risk breast cancer as defined by a Nottingham Prognostic Index (NPI) of \> 5\.4 will be considered for metastatic workup in the form of a 18 FDG PET CT. Alternatively, a CT scan of the thorax and whole abdomen, and a bone scan is also allowed. Metastatic workup will also be recommended in patients with AJCC 8 T3/T4 tumors at presentation, 4 or more nodes positive after surgery (pN2 or above). Patients with low or intermediate NPI will be considered for metastatic workup on a case by case basis. Metastatic workup will also be recommended for all patients undergoing neoadjuvant chemotherapy for locally advanced breast cancers.
- •6\. Clear margins of resection for the breast primary as defined by absence tumor on ink in the specimen if a breast conservation has been performed or excision upto the deep fascia of the pectoralis major or skin.
- •7\. Adjuvant radiotherapy is indicated. The following patients will be considered as candidates to receive adjuvant radiotherapy:
- •A. All patients after breast conservation surgery or after neoadjuvant chemotherapy
- •B. Patients after mastectomy if any of the below:
- •i. T3 \- T4 tumors
Exclusion Criteria
- •1\. Patients with pure ductal carcinomas in situ (in patients undergoing upfront surgery).
- •2\. Patients with non\-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
- •3\. Patients with metaplastic breast cancers
- •4\. Presence of pathologically proven residual supraclavicular nodal metastases or residual internal mammary lymphadenopathy at time of radiotherapy.
- •5\. Prior radiotherapy to the ipsilateral breast/chest wall or the mediastinum. Patients with synchronous / metachronous contralateral breast malignancies will be eligible for inclusion. Patients requiring bilateral breast radiotherapy are also eligible for inclusion.
- •Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- •7\. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
- •8\. Patients planned for concurrent chemotherapy during radiation therapy. Concurrent hormonal therapy or targeted therapy using anti\-HER2 agents is allowed.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving SurgeryBreast CancerNCT04025164Fudan University4,052
Recruiting
Not Applicable
One Week Versus Three Week in Adjuvant Radiotherapy in Breast CancerBreast Cancer FemaleNCT03788213Tata Medical Center2,100
Completed
Phase 1
Hypofractionated radiotherapy for low and intermediate-risk prostate cancer using robot-tracking stereotactic radiotherapy -phase I/II clinical trialprostate cancerJPRN-UMIN000014328Osaka University Graduate School of Medicine75
Recruiting
Phase 2
Two-fraction Ultra-hypofractionated Radiotherapy with Focal Boost for low- and intermediate risk, localized prostate cancer (TURBO):phase II, randomized controlled clinical trialprostate adenocarcinomaprostate cancer100276561001818810036958NL-OMON56580niversitair Medisch Centrum Utrecht160
Active, not recruiting
Not Applicable
Sequential hypofractionated radiotherapy followed by anti-PD-L1 atezolizumab for recurrent or refractory small cell lung cancerKCT0005443ational Cancer Center35