Esophageal CancerPhase 2/3POWERRANGERNCT01404156
Preoperative Chemotherapy vs. Chemoradiation in Esophageal / GEJ Adenocarcinoma
A Phase 2/3 study testing (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel and Carboplatin paclitaxel plus concurrent radiotherapy in people with Esophageal Cancer and Adenocarcinoma, Esophageal, run by Dr. Gordon Buduhan at 3 sites in Canada.
Trial summary
The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either perioperative (before and after surgery) chemotherapy or preoperative (before… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Cancer, Adenocarcinoma, Esophageal, Adenocarcinoma, Gastroesophageal Junction
- What is being tested?
- (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel and Carboplatin paclitaxel plus concurrent radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2015to Aug 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adenocarcinoma of esophagus or gastroesophageal junction; -cT1N1-3 or T2-4Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification
- proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia
- tumor length < 8cm; diameter < 5 cm
- age > 18 years
- absolute neutrophil count (ANC) ≥ 1.5 x 109 / L
- platelet count > 100 x 109 / L
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- creatinine clearance > 50 ml / min
- bilirubin < 1.5x upper limit normal
- FEV1 > 1.0 L
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Who cannot join
- positive serum / urine pregnancy test for females of childbearing age
- previous primary / recurrent malignancy in last 5 years (history of previous / current non-melanoma skin cancer or cervical in-situ carcinoma in last 5 years acceptable for inclusion in trial)
- previous chemotherapy for esophageal cancer
- previous radiation therapy that would overlap required radiation fields
- major systemic illness(es) that would limit life expectancy <2 years
- psychiatric / cognitive illness that would limit ability to give informed consent
- (Patients will be reviewed by both a medical and radiation oncologist and deemed fit to undergo either neoadjuvant chemotherapy or chemoradiation, respectively)
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
London Health Sciences Centre
London, Ontario, N6A 5W9
Toronto General Hospital / Princess Margaret Hospital
Toronto, Ontario
Health Sciences Centre / CancerCare Manitoba
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: PreOperative Treatment With chEmotheRapy or chemoRAdiatioN in esophaGeal or gastroEsophageal adenocaRcinoma
The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either perioperative (before and after surgery) chemotherapy or preoperative (before surgery) chemotherapy plus radiation is given, compared to surgery alone. However it is unknown which of these treatments (perioperative chemotherapy or preoperative chemoradiation) is more effective in improving survival. A study where patients with resectable esophageal / GE junction cancer are chosen at random to receive one of the two preoperative treatments would help determine if one form of treatment improves survival compared to the other.
Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized to receive either preoperative and postoperative chemotherapy or preoperative chemoradiation followed by surgery.
The main objective of this pilot trial is to determine the possibility of conducting a larger study with many centers participating. If this study proves to be feasible with enough patients enrolled and able to tolerate treatments without major side effects then we can hopefully proceed to perform a larger multi-center trial to look for survival outcome differences between patients who receive preoperative chemotherapy and those who receive preoperative chemoradiation. The results of this trial would ultimately help us choose the most effective treatment of resectable esophageal cancer and hopefully improve survival.
Read the detailed description
OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction.
RESEARCH PLAN Phase III randomized 2-arm parallel group pilot study
1:1 randomization to A) or B)
TREATMENT REGIMEN A) PERIOPERATIVE CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively: 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days
OR
- ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,) day 1 IV Cisplatin: 60 mg/m², day 1 IV 5-Fluorouracil: 200 mg/m², daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, BID (ECX)
OR
- NEOADJUVANT CHEMORADIATION
- -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29
- paclitaxel: 50 mg / m2 IV
- carboplatin: dosed to an area under the curve of 2, by Calvert formula Radiation Therapy 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk Upon completion of neoadjuvant therapy, all patients will be considered for surgery.
Patients will be deemed acceptable for surgery provided:
- repeat imaging performed after neoadjuvant therapy does not demonstrate distant metastases or local invasion of the primary tumor into vital structures (heart, great vessels, trachea)
- maintenance of adequate performance status and ability to tolerate esophagectomy
Surgery will be performed preferably within 8 weeks of completion of neoadjuvant therapy.
- Being tested
- (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel, Carboplatin paclitaxel plus concurrent radiotherapy
- Keywords
- Esophageal cancer, Neoadjuvant, Chemotherapy, Chemoradiation, Surgery, Esophagectomy, Adenocarcinoma, Gastroesophageal
- Medical subject headings
- Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin DocetaxelDrug
Also called ECF/ECX or FLOT
NEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2)
- FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days
- ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, PO BID (ECX)
Carboplatin paclitaxel plus concurrent radiotherapyOther
5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 preoperatively:
- paclitaxel: 50 mg / m2 IV over 1 hour
- carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion
Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.
- Dose specifications:
- Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints.
- Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment .
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemotherapy | Active comparator | NEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2)
1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days
2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous intravenous infusionIV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2 PO BID (ECX) Receives: Drug: (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel |
| Neoadjuvant Chemoradiation | Experimental | 1) -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29
* paclitaxel: 50 mg / m2 IV over 1 hour
* carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.
1. Dose specifications:
1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy.
2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment. Receives: Other: Carboplatin paclitaxel plus concurrent radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance with assigned neoadjuvant treatment
- >60% patients allocated for randomization will start and complete treatment without major protocol violation
Measured: 5 weeks for chemoradiation arm, 6-8 weeks for chemotherapy arm
treatment response
>30% of patients in both treatment arms demonstrate partial or complete response as defined by Mandard TRG 1-3 on pathologic staging
Measured: 5 weeks for chemoradiation arm, 6-8 weeks for chemotherapy arm
Secondary outcomes (2)
survival
3 year overall- and disease-free survival
Measured: 3 years
EORTC QOL
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 Version 3.0
Measured: baseline, 3, 6, 9, 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2015
- Primary completionAug 2023
- Study completionAug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Gordon Buduhan
- Sponsor type
- University, hospital or other
- Collaborators
- CancerCare Manitoba, University of Toronto, London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Dr. Gordon Buduhan, CancerCare Manitoba
- Investigators
- Gordon Buduhan, MD MSc FRCSC, Principal investigator, University of Manitoba / CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404156
- Sponsor's protocol ID
- CDHA 174431-7
- Acronym
- POWERRANGER
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2011
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PreOperative Treatment With chEmotheRapy or chemoRAdiatioN in esophaGeal or gastroEsophageal adenocaRcinoma
- ClinicalTrials.gov ID
- NCT01404156
- Acronym / sponsor ID
- POWERRANGER / CDHA 174431-7
- Keywords
- Esophageal cancer, Neoadjuvant, Chemotherapy, Chemoradiation, Surgery, Esophagectomy, Adenocarcinoma, Gastroesophageal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. Gordon BuduhanUniversity, hospital or other
- Collaborators
- CancerCare Manitoba, University of Toronto, London Health Sciences Centre
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2023 (actual)
- Study completion
- Aug 2023 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The best treatment for resectable esophageal or gastroesophageal adenocarcinoma is unknown. Although an operation to remove the esophagus is the most common treatment, previous studies have shown that patients live longer when either perioperative (before and after surgery) chemotherapy or preoperative (before surgery) chemotherapy plus radiation is given, compared to surgery alone. However it is unknown which of these treatments (perioperative chemotherapy or preoperative chemoradiation) is more effective in improving survival. A study where patients with resectable esophageal / GE junction cancer are chosen at random to receive one of the two preoperative treatments would help determine if one form of treatment improves survival compared to the other.
Patients with localized esophageal / GE junction cancer (adenocarcinoma) will be randomized to receive either preoperative and postoperative chemotherapy or preoperative chemoradiation followed by surgery.
The main objective of this pilot trial is to determine the possibility of conducting a larger study with many centers participating. If this study proves to be feasible with enough patients enrolled and able to tolerate treatments without major side effects then we can hopefully proceed to perform a larger multi-center trial to look for survival outcome differences between patients who receive preoperative chemotherapy and those who receive preoperative chemoradiation. The results of this trial would ultimately help us choose the most effective treatment of resectable esophageal cancer and hopefully improve survival.
Detailed description
OBJECTIVE To determine the feasibility of a randomized trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation for patients with resectable adenocarcinoma of the esophagus or gastroesophageal junction.
RESEARCH PLAN Phase III randomized 2-arm parallel group pilot study
1:1 randomization to A) or B)
TREATMENT REGIMEN A) PERIOPERATIVE CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively: 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days
OR
- ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,) day 1 IV Cisplatin: 60 mg/m², day 1 IV 5-Fluorouracil: 200 mg/m², daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, BID (ECX)
OR
- NEOADJUVANT CHEMORADIATION
- -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29
- paclitaxel: 50 mg / m2 IV
- carboplatin: dosed to an area under the curve of 2, by Calvert formula Radiation Therapy 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk 45-50.4 Gy in 25-28 fractions of 1.8 Gy/fraction, 5 fractions/wk Upon completion of neoadjuvant therapy, all patients will be considered for surgery.
Patients will be deemed acceptable for surgery provided:
- repeat imaging performed after neoadjuvant therapy does not demonstrate distant metastases or local invasion of the primary tumor into vital structures (heart, great vessels, trachea)
- maintenance of adequate performance status and ability to tolerate esophagectomy
Surgery will be performed preferably within 8 weeks of completion of neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemotherapy | Active comparator | Drug: (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin DocetaxelNEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days 2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous intravenous infusionIV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2 PO BID (ECX) |
| Neoadjuvant Chemoradiation | Experimental | Other: Carboplatin paclitaxel plus concurrent radiotherapy1) -carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 * paclitaxel: 50 mg / m2 IV over 1 hour * carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment. 1. Dose specifications: 1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. 2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adenocarcinoma of esophagus or gastroesophageal junction; -cT1N1-3 or T2-4Nx; M0 by American Joint Committee on Cancer (AJCC) 7th Edition staging classification
- proximal portion of the tumor at least 20 cm from the incisors on endoscopy, and extend no greater than 2 cm into the gastric cardia
- tumor length < 8cm; diameter < 5 cm
- age > 18 years
- absolute neutrophil count (ANC) ≥ 1.5 x 109 / L
Key exclusion criteria (7 listed)
- positive serum / urine pregnancy test for females of childbearing age
- previous primary / recurrent malignancy in last 5 years (history of previous / current non-melanoma skin cancer or cervical in-situ carcinoma in last 5 years acceptable for inclusion in trial)
- previous chemotherapy for esophageal cancer
- previous radiation therapy that would overlap required radiation fields
- major systemic illness(es) that would limit life expectancy <2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin DocetaxelAlso: ECF/ECX or FLOTNEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2) 1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days 2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, PO BID (ECX) | Drug | Neoadjuvant Chemotherapy |
| Carboplatin paclitaxel plus concurrent radiotherapy5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 preoperatively: * paclitaxel: 50 mg / m2 IV over 1 hour * carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment. 1. Dose specifications: 1. Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints. 2. Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment . | Other | Neoadjuvant Chemoradiation |
Primary outcome
compliance with assigned neoadjuvant treatment
Time frame: 5 weeks for chemoradiation arm, 6-8 weeks for chemotherapy arm
- >60% patients allocated for randomization will start and complete treatment without major protocol violation
treatment response
Time frame: 5 weeks for chemoradiation arm, 6-8 weeks for chemotherapy arm
>30% of patients in both treatment arms demonstrate partial or complete response as defined by Mandard TRG 1-3 on pathologic staging
2 secondary outcomes
survival
Time frame: 3 years
EORTC QOL
Time frame: baseline, 3, 6, 9, 12 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon Buduhan, MD MSc FRCSC principal investigator
University of Manitoba / CancerCare Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing (Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel and Carboplatin paclitaxel plus concurrent radiotherapy in people with Esophageal Cancer and Adenocarcinoma, Esophageal, run by Dr. Gordon Buduhan at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compliance with assigned neoadjuvant treatment (time frame: 5 weeks for chemoradiation arm, 6-8 weeks for chemotherapy arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.