Rectal AdenocarcinomaPhase 2NCT04418895
Neoadjuvant Therapy for Localized Rectal Adenocarcinoma
A Phase 2 study testing Chemoradiation, short course radiation therapy and mFOLFOX6 in people with Rectal Adenocarcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is a prospective, single-arm, single-center study of investigator's choice of total neoadjuvant therapy (TNT) or neoadjuvant chemoradiation in locally advanced rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Chemoradiation, short course radiation therapy and mFOLFOX6
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2021to May 2025
- Phase
- Phase 2
- 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
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 (See Appendix A. ECOG Performance Status Scale).
- Histological or cytological confirmation of rectal adenocarcinoma.
- Planned to receive treatment with neoadjuvant therapy, comprised of either 1) chemoradiation with concurrent fluoropyrimidine or short-course radiotherapy, or 2) total neoadjuvant therapy with fluoropyrimidine +oxaliplatin followed by chemoradiation or short-course radiotherapy. Rectal adenocarcinoma patients deemed candidates for neoadjuvant therapy include:
- Tumor staged as T3-4 or node-positive by pelvic MRI or endorectal ultrasound, or node-positive by CT scan; OR
Show all 12Show fewer
- Tumor fixed to extra colonic structures as determined by digital rectal examination; OR
- Tumor < 5 cm from sphincter mechanism.
- Willing and able to undergo baseline rectal tumor biopsy, and willing and able to donate blood for research purposes.
- Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 weeks after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label.
- Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 weeks after the last dose of study therapy.
- Subjects are willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
Who cannot join
- Patients with colon carcinomas that are too proximal to receive neoadjuvant therapy per routine clinical practice (i.e. with primary tumor proximal to or at the sigmoid colon).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive and is requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject Is not currently receiving anti-cancer therapy such as chemotherapy, radiation therapy, targeted therapy, immunotherapy, or hormonal therapy.
- Patients who are not candidates at the discretion of their treating physicians to receive neoadjuvant chemoradiation or total neoadjuvant therapy (e.g. poor performance status, significant comorbidities, clinically significant organ dysfunction).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: Biomarkers and Clinical Outcomes in Localized Rectal Adenocarcinoma Treated With Neoadjuvant Therapy
This study is a prospective, single-arm, single-center study of investigator's choice of total neoadjuvant therapy (TNT) or neoadjuvant chemoradiation in locally advanced rectal cancer. The standard of care for rectal adenocarcinomas that are triiodothyronine-thyroxine (T3-T4) or node positive has generally been comprised of neoadjuvant chemoradiation, followed by surgical resection and then adjuvant chemotherapy. More recently, TNT, comprised of neoadjuvant chemotherapy and chemoradiation followed by surgical resection, has been increasingly used as a standard therapy approach. While the use of TNT is increasingly common, prospective study of outcomes following TNT has been limited. Moreover, there are not any biomarkers known at this time that impact clinical decision-making or personalization of therapy in the treatment of rectal cancer. In this study, we will collect pre-treatment rectal adenocarcinoma specimens and determine clinical outcome, including pathologic complete response rate, post-treatment pathologic downstaging rate, recurrence-free survival (RFS), overall survival (OS) and neoadjuvant rectal score, among patients who are treated with standard neoadjuvant chemoradiation or TNT, with an aim to investigate how baseline biomarkers and changes in biomarkers with standard therapies may be associated with, and modulate, clinical outcomes.
Read the detailed description
At enrollment, subjects should be planned to receive either neoadjuvant chemoradiation or total neoadjuvant therapy, with the choice of regimen at the discretion of treating investigators. Subjects will have been staged as deemed consistent with standard of care, including either a pelvic Magnetic resonance imaging (MRI) and/or an endorectal ultrasound, and deemed to have either T3-T4 primary tumor or node-positive tumor.
Neoadjuvant Chemoradiation Subjects will undergo endoscopic tumor biopsy within 6 weeks of the start of standard of care chemoradiation. Subjects will also have a baseline peripheral blood sample collected.
Subjects will receive neoadjuvant chemoradiation per standard of care. This is typically comprised of radiotherapy with concurrent capecitabine 825 mg/m2 by mouth (po) two times daily (bid) (typically rounded to the nearest 500 mg dose) or infusional 5-fluorouracil (5FU). However, dosing and administration are at the discretion of the treating medical and radiation oncologist.
An acceptable alternative approach is short-course radiation therapy per standard of care, which is typically comprised of radiotherapy, with surgery within 1 week of completion of therapy or delayed for 6-8 weeks. Selection of the optimal radiation therapy approach is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. However, generally, short-course radiation therapy is not recommended for low-lying tumors less than 5 centimeters (cm) from the anal verge.
Occasionally patients with inadequate response after neoadjuvant chemoradiation may be recommended to proceed with subsequent consolidative chemotherapy with 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX) for 16-18 weeks before surgical resection. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. These subjects will be allowed to remain on study.
Surgery will occur approximately 4-8 weeks after chemoradiation or consolidative chemotherapy, depending on clinical factors (i.e. resectability, presence or absence of metastatic disease), although it may occur as soon as 1 week after completing short-course radiation therapy. The timing of surgical resection after completion of neoadjuvant therapy is at the discretion of the treating surgical oncologist. At the time of surgery, tumor samples and peripheral blood samples for correlative studies will be collected.
Subjects who do not receive preoperative mFOLFOX6 or CAPOX typically receive postoperative adjuvant chemotherapy with a fluoropyrimidine +/- oxaliplatin for an additional 16-18 weeks of therapy, if permitted based on recovery after surgical resection and post-surgical performance status. This treatment is at the discretion of the treating medical oncologist. Subjects will remain on study regardless of postoperative therapy administration or duration.
Total Neoadjuvant Therapy Subjects will undergo endoscopic tumor biopsy within 6 weeks of the start of standard of care treatment with chemotherapy. Subjects will also have a baseline peripheral blood sample collected.
Subjects who are intended to receive total neoadjuvant therapy will typically receive chemotherapy with mFOLFOX6 or CAPOX for 16-18 weeks, followed by chemoradiation. Dosing and administration are at the discretion of the primary medical and radiation oncologist. Alternative subsequent approaches such as short-course radiotherapy are also acceptable at the discretion of the treating medical and radiation oncologist.
Surgery will occur approximately 4-8 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease), although it may occur as soon as 1 week after completing short-course radiation therapy. The timing of surgical resection after completion of neoadjuvant therapy is at the discretion of the treating surgical oncologist. At the time of surgery, tumor samples and peripheral blood samples for correlative studies will be collected.
Duration of Therapy
The duration of therapy should be defined per the subject's standard of care. Reasons to discontinue treatment may include:
- Disease progression
- Inter-current illness that prevents further administration of treatment
- Unacceptable adverse event(s)
- Pregnancy
- Subject decides to withdraw from study treatment, or
- General or specific changes in the subject's condition render the subject unacceptable for further treatment in the judgment of the investigator.
- Subject has completed the treatment regimen
- Subject is lost to follow up
Duration of Follow Up After surgery, subjects will be followed with routine surveillance at the discretion of treating investigators. Subjects will be followed for survival and disease status for at least 3 years after surgery or until death, whichever occurs first.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Chemoradiation, short course radiation therapy, mFOLFOX6, CAPOX, fluoropyrimidine +/- oxaliplatin
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiationOther
Subjects will receive neoadjuvant chemoradiation per standard of care. This is typically comprised of radiotherapy of 5040 cGy (centigray) with concurrent capecitabine 825 mg/m2 by mouth (po) two times daily (bid) (typically rounded to the nearest 500 mg dose) or infusional 5-fluorouracil (5FU). However, dosing and administration are at the discretion of the treating medical and radiation oncologist.
short course radiation therapyRadiation
An acceptable alternative approach is short-course radiation therapy per standard of care, which is typically comprised of radiotherapy of 25 Gy (gray) in 5 fractions, with surgery within 1 week of completion of therapy or delayed for 6-8 weeks. Selection of the optimal radiation therapy approach is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. However, generally, short-course radiation therapy is not recommended for low-lying tumors less than 5 centimeters (cm) from the anal verge.
mFOLFOX6Drug
Also called leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin
possible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist.
CAPOXDrug
Also called Capecitabine, Oxaliplatin
possible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist.
fluoropyrimidine +/- oxaliplatinDrug
possible adjuvant chemotherapy regimen. Subjects who do not receive preoperative mFOLFOX6 or CAPOX typically receive postoperative adjuvant chemotherapy with a fluoropyrimidine +/- oxaliplatin for an additional 16-18 weeks of therapy, if permitted based on recovery after surgical resection and post-surgical performance status. This treatment is at the discretion of the treating medical oncologist. Subjects will remain on study regardless of postoperative therapy administration or duration.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm: Standard of Care | Experimental | Investigator's choice of total neoadjuvant therapy (TNT) comprised of neoadjuvant chemotherapy and chemoradiation followed by surgical resection; or neoadjuvant chemoradiation followed by surgical resection and then adjuvant chemotherapy. Receives: Other: Chemoradiation; Radiation: short course radiation therapy; Drug: mFOLFOX6; Drug: CAPOX; Drug: fluoropyrimidine +/- oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete pathologic response (pCR) rate
Anatomic stage for rectal cancer uses the American Joint Committee on Cancer (AJCC) Tumor/Node/Metastasis (TNM) system, which is based on:Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. Stage prefixes include "c" for clinical stage, "p" for pathological stage, and "y" to indicate that the clinical or pathologic classification has been determined after preoperative therapy
Complete pathologic response is defined as no disease on pathology at resection (ypT0N0).
Measured: At time of surgery (1- 26 weeks after completion of standard of care neoadjuvant treatment)
Secondary outcomes (6)
pathologic down staging rate
Defined as a decrease in Tumor (T) and/or Nodal (N) stage from baseline to pathologic post-treatment determination, without any increase in T, N, or M stage.
Measured: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
near pathological complete response (near-pCR) rate
Near-pCR will be defined as minimal tumor on pathology at resection (ypT0-1 N0).
Measured: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
R0 resection rate
R0 resection will be defined as resection of all appreciable disease with a margin > 1 millimeter (mm) distally, proximally, and radially/circumferentially.
Measured: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
Recurrence Free Survival (RFS) rate
Defined as the time from day 1 of neoadjuvant chemotherapy until definitive local or metastatic disease recurrence or death as a result of any cause.
Measured: 3 years after surgical resection
Overall Survival (OS) rate
Defined as the time from day 1 of neoadjuvant chemotherapy until death as a result of any cause.
Measured: 3 years after surgical resection
Median Neoadjuvant Rectal Score (NAR)
With clinical T stage (cT) comprised of 1, 2, 3, or 4; pathologic T stage (pT) comprised of 0, 1, 2, 3, or 4; and pathologic N stage (pN) comprised of 0, 1, or 2 (according to AJCC clinical rectal staging criteria)., the Neoadjuvant rectal score (NAR)will be calculated after resection as follows:
NAR = [5 pN - 3 (cT-pT) + 12]2 / 9.61
A higher score indicates poorer prognosis
Measured: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start13 Aug 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael S Lee, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418895
- Sponsor's protocol ID
- LCCC 1933
- Status last verified
- Nov 2021
- First submitted
- 2 Jun 2020
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Clinical Outcomes in Localized Rectal Adenocarcinoma Treated With Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04418895
- Acronym / sponsor ID
- LCCC 1933
- Conditions
- Rectal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Jun 2020 (actual)
- 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.
This study is a prospective, single-arm, single-center study of investigator's choice of total neoadjuvant therapy (TNT) or neoadjuvant chemoradiation in locally advanced rectal cancer. The standard of care for rectal adenocarcinomas that are triiodothyronine-thyroxine (T3-T4) or node positive has generally been comprised of neoadjuvant chemoradiation, followed by surgical resection and then adjuvant chemotherapy. More recently, TNT, comprised of neoadjuvant chemotherapy and chemoradiation followed by surgical resection, has been increasingly used as a standard therapy approach. While the use of TNT is increasingly common, prospective study of outcomes following TNT has been limited. Moreover, there are not any biomarkers known at this time that impact clinical decision-making or personalization of therapy in the treatment of rectal cancer. In this study, we will collect pre-treatment rectal adenocarcinoma specimens and determine clinical outcome, including pathologic complete response rate, post-treatment pathologic downstaging rate, recurrence-free survival (RFS), overall survival (OS) and neoadjuvant rectal score, among patients who are treated with standard neoadjuvant chemoradiation or TNT, with an aim to investigate how baseline biomarkers and changes in biomarkers with standard therapies may be associated with, and modulate, clinical outcomes.
Detailed description
At enrollment, subjects should be planned to receive either neoadjuvant chemoradiation or total neoadjuvant therapy, with the choice of regimen at the discretion of treating investigators. Subjects will have been staged as deemed consistent with standard of care, including either a pelvic Magnetic resonance imaging (MRI) and/or an endorectal ultrasound, and deemed to have either T3-T4 primary tumor or node-positive tumor.
Neoadjuvant Chemoradiation Subjects will undergo endoscopic tumor biopsy within 6 weeks of the start of standard of care chemoradiation. Subjects will also have a baseline peripheral blood sample collected.
Subjects will receive neoadjuvant chemoradiation per standard of care. This is typically comprised of radiotherapy with concurrent capecitabine 825 mg/m2 by mouth (po) two times daily (bid) (typically rounded to the nearest 500 mg dose) or infusional 5-fluorouracil (5FU). However, dosing and administration are at the discretion of the treating medical and radiation oncologist.
An acceptable alternative approach is short-course radiation therapy per standard of care, which is typically comprised of radiotherapy, with surgery within 1 week of completion of therapy or delayed for 6-8 weeks. Selection of the optimal radiation therapy approach is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. However, generally, short-course radiation therapy is not recommended for low-lying tumors less than 5 centimeters (cm) from the anal verge.
Occasionally patients with inadequate response after neoadjuvant chemoradiation may be recommended to proceed with subsequent consolidative chemotherapy with 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX) for 16-18 weeks before surgical resection. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. These subjects will be allowed to remain on study.
Surgery will occur approximately 4-8 weeks after chemoradiation or consolidative chemotherapy, depending on clinical factors (i.e. resectability, presence or absence of metastatic disease), although it may occur as soon as 1 week after completing short-course radiation therapy. The timing of surgical resection after completion of neoadjuvant therapy is at the discretion of the treating surgical oncologist. At the time of surgery, tumor samples and peripheral blood samples for correlative studies will be collected.
Subjects who do not receive preoperative mFOLFOX6 or CAPOX typically receive postoperative adjuvant chemotherapy with a fluoropyrimidine +/- oxaliplatin for an additional 16-18 weeks of therapy, if permitted based on recovery after surgical resection and post-surgical performance status. This treatment is at the discretion of the treating medical oncologist. Subjects will remain on study regardless of postoperative therapy administration or duration.
Total Neoadjuvant Therapy Subjects will undergo endoscopic tumor biopsy within 6 weeks of the start of standard of care treatment with chemotherapy. Subjects will also have a baseline peripheral blood sample collected.
Subjects who are intended to receive total neoadjuvant therapy will typically receive chemotherapy with mFOLFOX6 or CAPOX for 16-18 weeks, followed by chemoradiation. Dosing and administration are at the discretion of the primary medical and radiation oncologist. Alternative subsequent approaches such as short-course radiotherapy are also acceptable at the discretion of the treating medical and radiation oncologist.
Surgery will occur approximately 4-8 weeks after chemoradiation depending on clinical factors (i.e. resectability, presence or absence of metastatic disease), although it may occur as soon as 1 week after completing short-course radiation therapy. The timing of surgical resection after completion of neoadjuvant therapy is at the discretion of the treating surgical oncologist. At the time of surgery, tumor samples and peripheral blood samples for correlative studies will be collected.
Duration of Therapy
The duration of therapy should be defined per the subject's standard of care. Reasons to discontinue treatment may include:
- Disease progression
- Inter-current illness that prevents further administration of treatment
- Unacceptable adverse event(s)
- Pregnancy
- Subject decides to withdraw from study treatment, or
- General or specific changes in the subject's condition render the subject unacceptable for further treatment in the judgment of the investigator.
- Subject has completed the treatment regimen
- Subject is lost to follow up
Duration of Follow Up After surgery, subjects will be followed with routine surveillance at the discretion of treating investigators. Subjects will be followed for survival and disease status for at least 3 years after surgery or until death, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm: Standard of Care | Experimental | Other: Chemoradiation, Radiation: short course radiation therapy, Drug: mFOLFOX6, Drug: CAPOX, Drug: fluoropyrimidine +/- oxaliplatinInvestigator's choice of total neoadjuvant therapy (TNT) comprised of neoadjuvant chemotherapy and chemoradiation followed by surgical resection; or neoadjuvant chemoradiation followed by surgical resection and then adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2 (See Appendix A. ECOG Performance Status Scale).
- Histological or cytological confirmation of rectal adenocarcinoma.
- Planned to receive treatment with neoadjuvant therapy, comprised of either 1) chemoradiation with concurrent fluoropyrimidine or short-course radiotherapy, or 2) total neoadjuvant therapy with fluoropyrimidine +oxaliplatin followed by chemoradiation or short-course radiotherapy. Rectal adenocarcinoma patients deemed candidates for neoadjuvant therapy include:
Key exclusion criteria (4 listed)
- Patients with colon carcinomas that are too proximal to receive neoadjuvant therapy per routine clinical practice (i.e. with primary tumor proximal to or at the sigmoid colon).
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Has a known additional malignancy that is active and/or progressive and is requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject Is not currently receiving anti-cancer therapy such as chemotherapy, radiation therapy, targeted therapy, immunotherapy, or hormonal therapy.
- Patients who are not candidates at the discretion of their treating physicians to receive neoadjuvant chemoradiation or total neoadjuvant therapy (e.g. poor performance status, significant comorbidities, clinically significant organ dysfunction).
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 |
|---|---|---|
| ChemoradiationSubjects will receive neoadjuvant chemoradiation per standard of care. This is typically comprised of radiotherapy of 5040 cGy (centigray) with concurrent capecitabine 825 mg/m2 by mouth (po) two times daily (bid) (typically rounded to the nearest 500 mg dose) or infusional 5-fluorouracil (5FU). However, dosing and administration are at the discretion of the treating medical and radiation oncologist. | Other | Single Arm: Standard of Care |
| short course radiation therapyAn acceptable alternative approach is short-course radiation therapy per standard of care, which is typically comprised of radiotherapy of 25 Gy (gray) in 5 fractions, with surgery within 1 week of completion of therapy or delayed for 6-8 weeks. Selection of the optimal radiation therapy approach is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. However, generally, short-course radiation therapy is not recommended for low-lying tumors less than 5 centimeters (cm) from the anal verge. | Radiation | Single Arm: Standard of Care |
| mFOLFOX6Also: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatinpossible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. | Drug | Single Arm: Standard of Care |
| CAPOXAlso: Capecitabine, Oxaliplatinpossible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. | Drug | Single Arm: Standard of Care |
| fluoropyrimidine +/- oxaliplatinpossible adjuvant chemotherapy regimen. Subjects who do not receive preoperative mFOLFOX6 or CAPOX typically receive postoperative adjuvant chemotherapy with a fluoropyrimidine +/- oxaliplatin for an additional 16-18 weeks of therapy, if permitted based on recovery after surgical resection and post-surgical performance status. This treatment is at the discretion of the treating medical oncologist. Subjects will remain on study regardless of postoperative therapy administration or duration. | Drug | Single Arm: Standard of Care |
Primary outcome
complete pathologic response (pCR) rate
Time frame: At time of surgery (1- 26 weeks after completion of standard of care neoadjuvant treatment)
Anatomic stage for rectal cancer uses the American Joint Committee on Cancer (AJCC) Tumor/Node/Metastasis (TNM) system, which is based on:Size of primary tumor (T) and whether it has grown into nearby areas. Spread to regional lymph nodes (N). Spread (metastasis; M) to other organs of the body. Once the T, N, and M categories have been determined, this information is combined into a prognostic group. Higher numbers mean the cancer is more advanced. Stage prefixes include "c" for clinical stage, "p" for pathological stage, and "y" to indicate that the clinical or pathologic classification has been determined after preoperative therapy Complete pathologic response is defined as no disease on pathology at resection (ypT0N0).
6 secondary outcomes
pathologic down staging rate
Time frame: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
near pathological complete response (near-pCR) rate
Time frame: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
R0 resection rate
Time frame: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
Recurrence Free Survival (RFS) rate
Time frame: 3 years after surgical resection
Overall Survival (OS) rate
Time frame: 3 years after surgical resection
Median Neoadjuvant Rectal Score (NAR)
Time frame: At time of surgery (1-26 weeks after completion of standard of care neoadjuvant treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael S Lee, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiation, short course radiation therapy and mFOLFOX6 in people with Rectal Adenocarcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 12 inclusion and 4 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: withdrawn, as of the sponsor's last update on 10 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
complete pathologic response (pCR) rate (time frame: At time of surgery (1- 26 weeks after completion of standard of care neoadjuvant treatment)). 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 10 Nov 2021.